Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Oct 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special gel called a hydrogel spacer, which is placed between the prostate and the rectum, to help reduce side effects during salvage radiation therapy for prostate cancer. The goal is to minimize bowel problems and improve the quality of life for patients who have had prostate cancer that has returned after previous treatment. The researchers hope that by keeping the radiation dose away from the rectum, they can make the treatment safer and more comfortable for patients.

To be eligible for this trial, participants must have confirmed locally recurrent prostate cancer and be willing to provide informed consent. They should also be able to complete some questionnaires about their health. However, people who have certain medical conditions or have had specific types of previous radiation treatments may not be able to join. Those who participate can expect to undergo the procedure to place the hydrogel spacer and then receive the salvage radiation therapy, with regular follow-ups to check on their health and any side effects. This trial is currently recruiting male participants aged 65 to 74.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically and radiologically confirmed locally recurrent prostate adenocarcinoma
• • Willing to give informed consent to participate in this clinical trial
• • Able and willing to complete EPIC and EQ-5D questionnaires
• Exclusion Criteria:
• • Contraindication to prostate MRI
• • Anticoagulation medication (if unsafe to discontinue)
• • Diagnosis of bleeding diathesis
• • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
• • Evidence of castrate resistance (defined as PSA \> 3 ng/ml while testosterone is \< 0.7nmol/l). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
• • Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
• • Prior ultra-hypofractionated radiotherapy ( SBRT of 5Gy/fraction or higher)